1. Field of the Invention
This invention relates to a skin treatment and, more particularly, to an apparatus and method for treating skin to promote hair growth.
2. Description of the Related Art
Certain skin treatments are directed to skin rejuvenation, such as micro needling. The earliest form of micro needling, acupuncture, traces its roots to the Chinese centuries ago. A French skin rejuvenation technique, called nappage, has been used within the past fifty years. Nappage is another form of micro needling in which micro incisions are made into the skin placing a drop of vitamins, minerals and anti-oxidants to replace depleted cellular levels.
A major advantage provided by micro needling is the preservation of the epidermis, the protective layer of the skin. The publication entitled “Minimally Invasive Percutaneous Collagen Induction” by D. Fernandes, J Oral Maxillofac Surg Clin North Am. 2005 at 17:51-63, discloses the benefits of preserving the epidermis.
The publication entitled “Subcutaneous Incision-less (Subcision) Surgery for the Correction for Depressed Scars and Wrinkles” by D. S. Orentreich et al., Dermotol Surg, 1995, 21:543-549, discloses a skin treatment in which subcision with a needle is used to treat wrinkles near the lip lines.
The publication entitled “Needle Dermabrasion” by A. Camirand et al., Aesthetic Plast Surg. 1997; 21:48-51, discloses that hypochromic facial scars become tattooed with a skin color pigment over time. The skin color pigment is replaced with melanin within one to two years. The appearance, the color, and the texture of the scars improve through micro needling.
The publication entitled “Reflections about Collagen-Induction-Therapy (CIT)—A Hypothesis for the Mechanism of Action of CIT using Micro-Needles” by Schwartz et al., 1st edition February 2006, 2nd revision January 2007, discloses new collagen and elastin formation at 6 weeks after “dry” micro needling. The term “dry microneedling” refers to microneedling in which no substance was used or infused into the skin. The study demonstrated a substantial increase in new collagen fibers. The fibers were only found at the corium not deeper than 0.5 mm to 0.6 mm. Even though 1.5 mm needles were used, no new collagen fibers could be found in the sub dermal layer illustrating no benefit to using longer more invasive needles. The study also evaluated the penetration forces and needle length.
Other types of skin treatments are directed to treating hair loss. Hair loss including androgenetic alopecia, also known as male-pattern or female-pattern hair loss, represents approximately fifty percent of cases involving hair loss in the United States. Hair loss may also be caused by environmental and genetic factors unrelated to androgens including alopecia greata, permanent alopecia, anagen effluvium, lichen planopilaris and discoid lupus erythematosus.
Current Food and Drug Administration (FDA) approved skin treatments for hair loss include two pharmaceutical treatments and low level light or “cold laser” therapy. Pharmaceuticals used in the treatment of androgenetic alopecia stimulate existing hair follicles to produce thicker hair and prevent hair thinning. The pharmaceutical treatments include topical minoxidil (sold under the trademark Rogaine® by Pfizer) and oral Finasteride (sold under the trademark Propecia® by Merck). Humans are born with a finite number of approximately 100,000 terminal hair follicles on the scalp.
The existing pharmaceutical treatments inhibit the effects of androgens. Individuals who are genetically susceptible to the effects of androgens experience shortened hair growth cycles, which manifest in thinning and bitemporal recession of hair.
Both pharmaceutical treatments attack the effects of dihydrotestosterone. However, neither drug restores all the hair. Neither treatment produces new follicles. Both treatments require prolonged usage of the drug, and if treatment is stopped, any benefits gained will be lost. In such instances, the hair thickness regresses to pre-treatment levels.
Reversible side effects are associated with the use of these androgen inhibitors. These side effects include decreased libido, erectile dysfunction, and dermatologic discomfort.
Other modalities for treating hair loss include in vivo hair transplantation whereby donor hair follicles from areas of the scalp that are insensitive to the effects of androgens are transplanted to areas experiencing irregular hair follicle cycling or areas with few hair follicles.
Hair transplantation can be assisted through the use of growth factors. Growth factors act in the bulge area of a hair shaft, below the sebaceous gland where stem cells are found. Growth factors interact with cells of a matrix to activate the proliferative phase of the hair. Stem cells are more primitive and of ectodermal origin. Stem cells give origin to the epidermal cells and the sebaceous glands. Cells of the dermal papilla, which are found at the capillary base, are of mesenchymal origin. Both cells need each other and interact through the action of various growth factors to give rise to the future follicular unit.
U.S. Pat. No. 6,649,072 discloses a method for producing a mixture of platelet-rich plasma and concentrated platelet-poor plasma. The method creates a natural protein extra cellular matrix (ECM) that entraps various growth factors (GF), which allows cells to attach and proliferate.
The publication entitled “Synergistic Signaling from Extra cellular Matrix-Growth Factor Complexes” by R. Clark et al., Journal of Investigative Dermatology (2008) 128, 1354-1355. doi:10.1038/jid.2008.75, discloses that “GF-ECM complexes may well be the most effective and efficient method to stimulate cell proliferation, as well as tissue healing or regeneration.”
Platelet rich plasma (platelet-rich plasma) contains several growth factors, including platelet-derived growth factors (PDGF), transforming growth factor-beta 1 (TGF-beta 1) at high levels and vascular endothelial growth factor (VEGF). When platelets are activated growth factors are released which emit chemical signals to surrounding areas multiplying the growth factors thus causing a heighten “immune response”.
The main function of PDGF is to stimulate cell replication (mitogenesis) of healing capable stem cells. The publication entitled “The Importance of Growth Factors in Wound Healing” by V. Declair, Ostomy Wound Manage, 45, 64-68 (1999), discloses that growth factors are essential for the regulation of the cellular events involved in wound healing by attracting cells to the wound, stimulating proliferation, and significantly influencing matrix deposition.
The publication entitled “TGF-beta and Retnoic Acid Regulation of Growth and Modifiers of Differentiation Human Epidermal Cells” by Y. Choi and E. Fuchs, E., Crell regal. 1, 791-809 (1990), discloses that TGF-beta is extremely important because it affects most aspects of tissue wound repair, namely initiation and termination and also promotes differentiation and proliferation.
Fibroblasts are among the cells that are activated by TGF-beta. When a fibroblast is activated, the fibroblast will undergo cell division to produce collagen. Collagen deposition is responsible for plumping the skin and reversing the visible signs of aging.
The publication entitled “Platelet-Derived Growth Factor” by R. Ross, Am Rev. Med. 38, 71-79 (1986) discloses that PDGF improves dermal regeneration, acts locally to promote protein and collagen synthesis, and causes endothelial migration or angiogenesis. The publication entitled “Transforming Growth Factor B Reverses the Glucocorticoid-induced Wound Healing Defect in Rats: Possible Regulation in Microphages by Platelet-Derived Growth Factor” by G. F. Pierce, T. A. Mustoe, J. Lingelbach, V. R. Masakowski, P. P. Gramates, T. F. Deuel, Proc. Natl. Acad. Sci., 86, 2229-2233 (1989), discloses that PDGF induces the expression of TGF-beta.
The publication entitled “Involvement of Platelet Derived Growth Factor Receptor-a in Hair Canal Formation” by N. Takakura et al., Journal of Investigative Dermatology. (1996) 107, 770-777, discloses that PDGF signals are involved in epidermis-follicle interaction and dermal mesenchyme interaction. Epidermis-follicle interaction is required for hair canal formation. Dermal mesenchyme interaction is required the growth of dermal mesenchyme.
PDGF also performs other functions. The publication entitled “Platelet-Derived Growth Factor” by R. Ross, Am Rev. Med. 38, 71-79 (1986) discloses that PDGF improves dermal regeneration, acts locally to promote protein and collagen synthesis, and causes endothelial migration or angiogenesis. The publication entitled “Transforming Growth Factor B Reverses the Glucocorticoid-induced Wound Healing Defect in Rats: Possible Regulation in Microphages by Platelet-Derived Growth Factor” by G. F. Pierce, T. A. Mustoe, J. Lingelbach, V. R. Masakowski, P. P. Gramates, T. F. Deuel, Proc. Natl. Acad. Sci., 86, 2229-2233 (1989), discloses that PDGF induces the expression of TGF-beta.
The publication entitled “Involvement of Platelet Derived Growth Factor Receptor-a in Hair Canal Formation” by N. Takakura, H. Yoshida, T. Kunisada, S. Nishikawa, J. of Investigative Dermatology, (1996), 107, 770-777, discloses that PDGF signals are involved in both epidermis-follicle interaction and the dermal mesenchyme interaction required for hair canal formation and the growth of dermal mesenchyme.
The publication entitled “Control of Hair Growth and Follicle Size by VEGF-mediated Angiogenesis” by K. Yano et al., J Clin Invest, February 2001, Volume 107, Number 4, 409-417, identifies VEGF as a major mediator of hair follicle growth providing the first direct evidence of follicular revascularization. The publication discloses that improved follicle revascularization promotes hair growth, increases follicle size, and increases hair size.
The publication entitled “Substrate-Bound Insulin-Like Growth Factor (IGF)-I-IGF Binding Protein-Vitronectin-Stimulated Breast Cell Migration Is Enhanced by Coactivation of the Phosphatidy linositide 3-Kinase/AKT Pathway by v-Integrins and the IGF-I Receptor” by Z. Upton et al. discloses that vitronectin (VN) complexes with insulin-like growth factor (IGF) and IGF-binding proteins (IGFBPs) could enhance migration of human keratinocytes in vitro and possibly in vivo.
U.S. Patent Publication No. 2008/0248083 discloses an enriched platelet-containing mixture for treating injuries. The mixture is isolated from whole blood and resuspended in a small volume of plasma. The platelets are living, terminal cytoplasmic portions of marrow megakaryocytes that have no nucleus for replication and die off in 5-9 days. The platelets adhere together to form a platelet plug at an injury site and actively extrude the growth factors involved in initiating wound healing. These growth factors, also called cytokines, are small proteins each of about 25,000 Daltons molecular weight. They are stored in granules in platelets. In response to platelet to platelet aggregation or platelet to connective tissue contact, the cell membrane of the platelet is “activated” to release these alpha granules. These growth factors include PDGF, transforming growth factor beta 1 and 2 (TGF-β), fibronectin (FN), VN, fibrin and insulin-like growth factor (ILGF). These growth factors function to assist the body in repairing itself by stimulating stem cells to regenerate new tissue and by promoting vascularization.
The publication entitled “Our Experience Utilizing Autologous Platelet Rich Plasma in all Phases of Hair Transplant Surgery” by J. Greco et al., Hair Transplant Forum International, July-August, 2007, pp 131-132, discloses that platelet-rich plasma and PDGF can be used in hair transplantation surgery. The publication discloses the bathing of hair grafts in activated platelet-rich plasma to increase graft survival and yield in hair restoration surgery. The publication discloses that using platelet-rich plasma as a graft storage medium provides quicker healing.
U.S. Patent Publication No. 2007/0258956 discloses treatments for androgenetic alopecia and other forms of hair loss by inducing and expediting the growth of hair in the scalp of a patient. The disclosure includes the steps of isolating adipose-derived cells and hair follicles from the patient and implanting the combined cells and follicles into the scalp in areas requiring new growth of hair. The use of differentiated and undifferentiated adipose-derived cells with processed and grafted hair follicles for the therapeutic and cosmetic treatment of hair loss in vivo is disclosed. The use of adipose-derived cells with platelet concentrate or platelet-rich plasma is also disclosed.
U.S. Patent Publication No. 2003/0198687 discloses a method for promoting hair growth using platelet-rich plasma. The platelet enriched plasma is injected into subcutaneous tissue to promote hair growth.
U.S. Pat. No. 4,957,742 discloses a method for promoting hair growth using platelet enriched plasma. The platelet enriched plasma is applied to tissue to promote hair growth.
U.S. Pat. No. 5,178,883 discloses a method for preparing platelet enriched plasma. The platelet enriched plasma is applied to tissue to inter alia promote hair growth.
U.S. Pat. No. 5,165,938 discloses a method for preparing platelet enriched plasma. The platelet enriched plasma is applied to tissue to treat wounds.
The publication entitled “Plate-rich Plasma Gel Promotes Differentiation and Regeneration during Equine Wound Healing” by C. A. Carter, D. G. Jolly, C. E. Worden, D. G. Hendren, C. J. M. Kane, Experimental and Molecular Pathology, 74 (2003) at 244-255, discloses that wounds treated with platelet-rich plasma gel exhibit enhanced wound repair and possess more organized collagen. The use of platelet-rich plasma gel does not result in excessive disposition of connective tissue or scar formation.
U.S. Pat. Nos. 6,811,777 and 7,314,617 disclose the use of platelet-rich plasma for treating an injury. The term injury refers to any tissue damage including a wound, trauma or lesion or any tissue degeneration. In particular, the inventive platelet compositions may be used to treat incomplete repair of various connective tissues.
U.S. Patent Publication No. 2008/0193424 discloses a treatment of tissue defects using a therapeutic composition. The composition may include a mixture of platelet-rich plasma and concentrated platelet poor plasma. The composition is used to treat traumatized regions of the body.
U.S. Patent Publication No. 2007/0280959 discloses a new use for platelets or platelet rich plasma that is obtained by disruption of membranes for the preparation of an agent for the treatment of bone, cartilage or skin.
U.S. Patent Publication No. 2006/0057224 discloses a method for treating an open wound using platelet poor plasma and platelet rich plasma as a sealant.
U.S. Patent Publication No. 2003/0007957 discloses a method for treating wounds in traumatized areas using platelet-rich plasma with a structural matrix.
U.S. Pat. Nos. 6,303,112 and 7,112,342 disclose the use of an improved platelet gel wound healant for treating traumatized regions of the body. The improved wound healant includes a therapeutically effective amount of activated growth factors and ascorbic acid.
U.S. Pat. No. 7,011,852 discloses a method for separating, retrieving and concentrating platelets from whole blood relying on aggregation of the platelets followed by filtration. The purpose of this method is to prepare a platelet-rich plasma composition for treating injuries.
U.S. Pat. No. 6,284,285 discloses a method for obtaining fibrinogen and other growth factors to form a platelet-rich plasma composition. The platelet-rich plasma composition is used to promote tissue repair.
U.S. Pat. No. 5,599,558 discloses a method of making platelet releasate product. The platelet releasate product has many applications, including for the promotion of hair growth.
The publication entitled “Platelet Rich Plasma Gel Promotes Differentiation and Regeneration during Equine Wound Healing” by C. Carter, Experimental and Molecular Pathology 74; 244-55 (2003), discloses that platelet-rich concentrate enhances wound repair, decreases scar collagen, enhances Type III collagen, and increases wound tensile strength. Accordingly, there is a need to provide an improved treatment that promotes hair growth and rejuvenates skin.